The AstraZeneca logo.
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London: AstraZeneca has voluntarily withdrawn its marketing authorisation application with the EU's medicines regulator for its experimental precision drug for the treatment of a type of lung cancer, it said on Tuesday.
The drug, datopotamab deruxtecan (Dato-DXd), which has been jointly developed with Japan's Daiichi Sankyo, was granted a breakthrough therapy designation by the US Food and Drug Administration earlier this month for treatment of the same type of lung cancer when other treatments have failed.
The company said in its statement that its decision came following feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency. Its application was based on data from a late-stage trial, TROPION-Lung01.
Data from that trial has repeatedly knocked the company's shares, most recently in September when results showed that the drug did not significantly improve overall survival results for patients.
The drug belongs to a promising class known as antibody drug conjugates (ADC), which consist of tumour-seeking monoclonal antibodies that are combined with a cell-killing chemotherapy payload.